It is now generally acknowledged that indwelling catheterization in medical, surgical, gynecological, urological and other patients leads to serious infection of the urogenital tract. Despite the use of most careful aseptic techniques undertaken while the catheter is in the patient, approximately fifty percent of the patients develop an infection when a catheter is in place for twenty four hours, and approximately ninety-eight to one hundred percent of the patients develop an infection after four days of open indwelling catheter drainage. This is harmful to the patient because they are subjected to the risk of cystitis, acute pyelonephrititis, and life-threatening septicemia which carries a risk of mortality, as reported in Arch. Internal Med., Vol. 110, pages 703 to 711, 1962; Antimicrob. Agents Chemother., pages 617 to 623, 1963; and, Lancet, Vol. 1, pages 310 to 312, 1960.
The occurrence of the above-mentioned infection is encouraged by many circumstances. These include prolonged use of indwelling Foley catheters often accompanied by the absence of sterile insertion and maintenance techniques, having the catheter connected to clean but not sterile drainage collection containers placed in the immediate vicinity of the patient's bed. The presence of urinary pathogens in the container which multiply and enter the tract through the ascending catheter which is a major pathway of infection, the use of drainage systems made without a valve designed to prevent ascending pathogen migration through the catheter, and the use of nonprofessional ward personnel for monitoring the indwelling catheter and the drainage system. These and other circumstances that predispose a patient to infection are reported in Urinary Tract Infection and Its Management, edited by Kaye, D., Chapter 15, Care of the Indwelling Catheter, pages 256 to 266, 1972, published by The C. V. Mosby Company, St. Louis. Mo.
Attempts have been made to reduce the incidence of catheter-acquired infection, but these have not met with general acceptance. For example, one such attempt consists of systemic chemoprophylaxis achieved by administering either chloramphenicol or penicillin and streptomycin but this affords no significant protection against the acquisition of infection after indwelling catheterization as reported in Arch. Internal Med., Vol. 110, pages 703 to 711, 1962; Acta Chiv. Scand., Vol. 118, pages 45 to 52, 1959; and Dis. Mon., pages 1 to 36, September 1960. Another attempt for controllng infection consists in adding formalin to the collection container. However, this method does not enjoy general use because there is a risk of siphoning formalin into the urinary tract, and more importantly, since the formalin is in the container distant from the catheter, it does not provide any protection against pathogens traveling an ascending catheter; see British Medical Journal, Vol. 2, pages 423 to 425, 1964. One other attempt known to the art for preventing infection consists in placing an interruption in the catheter to prevent pathogen migration from a container to the patient. The purpose of the interruption was to discourage communication of the infection to the patient, as disclosed in U.S. Pat. No. 3,750,372. This design, however, it not widely used as it lacks means for preventing pathogen multiplication in the entire collection system and because the presence of small amounts of moisture in the interruption acts as a highway for pathogens can travel to the patient. In U.S. Pat. No. 3,908,659 one way valves are disclosed for establishing in drainage systems a barrier to pathogen migration; but these, too, are unsatisfactory because the valve retains liquid which liquid then provides the pathogens with a path around the barrier. It will be appreciated by those versed in the art, that in view of the above presentation, a critical need exists for a patient care collection system having in cooperation therewith a device for preventing and controlling the presence of unwanted pathogens in the system, and if such were made available, it would represent a valuable and useful contribution to the practicing art.